MAUDE Adverse Event Report: Covidien CHOCOLATE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	CB1413535040OTW
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of a 90% stenotic, 30 mm plaque lesion in the mid right tibial/popliteal trunk peripheral artery, with minimal tortuosity and a 4 mm vessel diameter, a 3.5 x 40 chocolate.014 percutaneous transluminal angioplasty balloon catheter was used through a 6f destination sheath.The vessel was pre-dilated with a 3 x 80 nanocross percutaneous transluminal angioplasty balloon catheter, and the lesion remained visible on fluoroscopy.After the chocolate balloon catheter was opened, inspected, and flushed, resistance was felt when backloading a.014 command guidewire through the catheter.The guidewire was removed, a new.014 command es guidewire was opened, and the chocolate catheter was re-flushed and backloaded without issue.The chocolate catheter was tracked through the lesion and inflated without issue using 50/50 contrast.The catheter was removed for follow-up dsa imaging, and the lesion remained visible.Extreme resistance was encountered when reloading the chocolate catheter over the.014 command guidewire.Difficulty removing the chocolate catheter and flushing the balloon catheter lumen were reported.The chocolate catheter and gui dewire were removed safely, a.035 glidewire advantage was advanced, and the lesion was post-dilated with a 4 x 60 evercross percutaneous transluminal angioplasty balloon catheter without additional issues.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis the returned device was flushed, (photo 3) and a 0.014¿ guidewire was loaded without any difficulties, medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CHOCOLATE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): Covidien; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): Covidien; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50929054
• Report Number: 2183870-2026-00474
• Device Sequence Number: 10734749
• Product Code: LIT
• UDI-Device Identifier: 00763000500061
• UDI-Public: (01)00763000500061(17)281129(10)2301028(20)05
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CB1413535040OTW
• Device Lot Number: 2301028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male